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The Caya® contoured diaphragm is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception. It is recommended for use with a contraceptive gel.

The Caya® contoured diaphragm is a contoured, flexible, single-sized, silicone elastomer cup for covering the cervix that is circumscribed by a rim encapsulating a nylon spring. The Caya contoured diaphragm has an anatomically shaped spring that has been designed to fit women representing a range of traditional diaphragm sizes.

The document describes the Caya® contoured diaphragm and its clinical study to demonstrate substantial equivalence to a predicate device, the ORTHO® ALL-FLEX® Diaphragm.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" but rather describes a non-inferiority finding compared to a historical control group using the predicate device. The primary performance metric is the 6-month Kaplan-Meier cumulative typical-use pregnancy probability.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Pivotal Study): 450 couples recruited.
  • 300 couples randomized to Caya® contoured diaphragm (referred to as SILCS diaphragm) with BufferGel.
  • 150 couples randomized to Caya® contoured diaphragm with N-9 spermicide gel.
• Data Provenance: The pivotal study for the Caya® contoured diaphragm was conducted at six sites in the United States. It was a prospective study. The historical control data for the predicate device was from a multi-center contraceptive study conducted by the National Institute for Child Health and Human Development (NICHD), likely also from the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For a contraceptive device's effectiveness study, the "ground truth" of pregnancy is typically established by medical diagnosis (e.g., urine/blood tests in a clinical setting by trained medical staff), not typically by "experts" in the way an imaging study would use radiologists. The document mentions "Study outcomes included pregnancy probability, safety, acceptability, diaphragm fit, and ease of use." Medical professionals at the study sites would have been responsible for diagnosing pregnancy and assessing other outcomes.

4. Adjudication Method for the Test Set

This information is not provided beyond the general design of a randomized controlled trial. For pregnancy, the outcome is relatively clear. For safety or device fit/ease of use, the document doesn't detail any specific adjudication committee or method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is a physical contraceptive diaphragm, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The primary ground truth for the pivotal study was pregnancy outcomes. This would have been established through clinical diagnosis by medical professionals at the study sites. Other outcomes included safety (e.g., adverse events diagnosed by medical staff), acceptability, diaphragm fit, and ease of use (likely assessed via patient questionnaires and clinician evaluations).

8. The Sample Size for the Training Set

This information is not applicable as the Caya® contoured diaphragm is a physical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The device underwent design, development, and evaluation, which involved iterative testing, but not a "training set" of data for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as #8. Design and development involved various engineering, biocompatibility, and preliminary clinical tests (like the Phase I post-coital study), but these are part of product development and validation, not "training an algorithm."

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The ORTHO® ALL-FLEX® Diaphragm, in conjunction with an appropriate spermicide, is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception.

The ORTHO® ALL-FLEX® Diaphragm (arcing spring), is a molded, buff-colored, shallow silicone rubber cup with a flexible rubber covered spring rim. The ORTHO® ALL-FLEX® Diaphragm vaginal diaphragm contains a distortion-free, dual spring-within-a-spring that provides unique arcing action no matter where the rim is compressed. It is appropriate for use not only where ordinary diaphragms are indicated, but also in patients with mild cystocele, rectocele or retroversion.

The provided text is a 510(k) summary for the ORTHO® ALL-FLEX® Diaphragm. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this type of document, as they are not the primary focus of a 510(k) for a diaphragm. A 510(k) of this nature typically relies on comparisons of technological characteristics to existing legally marketed devices.

However, I can provide what information is available and indicate where the requested information is not present or not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present specific quantitative acceptance criteria or reported device performance in terms of contraceptive efficacy rates (e.g., Pearl Index) as would be demonstrated in a clinical trial. Instead, it demonstrates substantial equivalence by comparing technological characteristics and intended use.

The "acceptance criteria" here are implicitly meeting the functional and safety characteristics of the predicate devices.

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of performance evaluation (e.g., a clinical trial with a specific number of subjects). The evaluation is based on a comparison of the device's technical specifications and intended use against legally marketed predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. As no clinical "test set" with ground truth determination is described, this information is not applicable. The substantial equivalence determination is made by the FDA based on the provided technical information and comparison to predicates, not by experts establishing clinical ground truth for a test set.

4. Adjudication method for the test set

N/A. No clinical "test set" or adjudication process described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This device is a physical medical device (diaphragm) and not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

N/A. This is a physical non-AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

N/A. For a 510(k) of this nature, the "ground truth" for substantial equivalence is based on established technical standards and the performance of legally marketed predicate devices. Clinical outcomes data or expert consensus for the new device's performance is not part of this 510(k) summary, as it's not a new technology requiring such a demonstration for initial market clearance under the substantial equivalence pathway.

8. The sample size for the training set

N/A. This is a physical non-AI device; therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

N/A. No training set is applicable.

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Milex Wide-Seal Silicone Diaphragms, in conjunction with an approved spermicidal gel or cream are indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception.

The Milex Wide-Seal contraceptive diaphragm is a shallow cup with a flexing rim. The diaphragm is composed of silicone. The diaphragm is placed over the cervix and coated with spermicidal cream or gel to prevent pregnancy. The diagrams are offered in the following sizes: 60mm, 65mm, 70mm, 75mm, 80mm, 85mm, 90mm, 95mm. The diaphragms are offered in two styles: Omniflex (Flat or Coil Style that folds in one place only) and Arcing (Folds in any place to form an arc or bow for insertion).

Here's an analysis of the provided text regarding the acceptance criteria and study for the CooperSurgical Milex Wide-Seal Diaphragms:

Based on the provided 510(k) summary, the device is a contraceptive diaphragm. The submission asserts substantial equivalence to a predicate device, the Ortho McNeil Diaphragm.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not contain information about a specific test set or clinical study conducted for this submission with a defined sample size for efficacy or safety. The device's approval is based on substantial equivalence to a predicate device (Ortho McNeil Diaphragm) which was pre-amendment (meaning it was on the market prior to May 28, 1976, and did not undergo the same regulatory scrutiny as new devices). The document broadly mentions "Over 500,000 Milex silicone Diaphragms have been distributed since the device was introduced in 1962," but this refers to historical distribution rather than a controlled study's test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. The submission does not describe a study involving human experts establishing ground truth for a test set.

4. Adjudication Method

Not Applicable. There is no described study or test set requiring an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This type of study is for evaluating observer performance (e.g., radiologists interpreting images) with and without AI assistance. The device in question is a physical contraceptive diaphragm, not an AI software.

6. Standalone (Algorithm Only) Performance Study

Not Applicable. This device is a physical product, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the current 510(k) submission is historical market performance and regulatory status of the predicate device (Ortho McNeil Diaphragm), coupled with the assumption that the new device, due to its similar design and intended use (despite material changes), would perform equivalently. The predicate's long-standing use (since 1962) implicitly served as evidence of its general safety and effectiveness.

8. Sample Size for the Training Set

Not Applicable. As this is a physical medical device and not an AI/algorithmic device, there is no concept of a "training set" in the context of this 510(k) submission.

9. How Ground Truth for the Training Set Was Established

Not Applicable. (See #8)

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided 510(k) summary does not describe a specific clinical study with a defined methodology, sample size, or measured performance endpoints for the Milex Wide-Seal Diaphragm to prove it meets acceptance criteria in the conventional sense.

Instead, the "study" that proves the device meets acceptance criteria is fundamentally a comparison to a legally marketed predicate device (Ortho McNeil Diaphragm) through the 510(k) substantial equivalence pathway.

The core argument for the device meeting the implicit acceptance criteria (safety and effectiveness) is:

• Substantial Equivalence: The subject device has the same intended use, similar technological characteristics, and (according to the manufacturer) is as safe and effective as the predicate device. The primary difference is material composition (silicone vs. natural rubber).
• Performance Data (Non-Clinical):
  • Biocompatibility testing.
  • Cleaning validation.
  • Functional/mechanical testing.
  • All these tests were "passed." (No specific results or criteria are provided in this summary).
• Historical Context: The statement that "Over 500,000 Milex silicone Diaphragms have been distributed since the device was introduced in 1962" suggests a history of real-world use for this type of device, which likely supported the safety argument.

In essence, the "proof" is based on non-clinical testing demonstrating the device's physical properties and biocompatibility, combined with the regulatory finding of substantial equivalence to a long-marketed predicate device. There is no mention of a prospective clinical trial, expert review of data, or comparative effectiveness study against specific efficacy metrics within this document.

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This is not a stand-alone device. It should be used in conjunction with your present contraceptive method.

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I am sorry, but the provided text from the FDA letters for K954183 (Ovurite, Ovulation Calculator) does not contain information about the acceptance criteria for a study, performance data the device, sample sizes, ground truth establishment, or details of comparative effectiveness studies.

The letters are primarily administrative communications from the FDA:

• The July 11, 2022, letter is an administrative change notification regarding the device's regulation number.
• The February 29, 1996, letter is the original substantial equivalence (SE) determination letter, which permits the device to be marketed as an accessory to a contraceptive method and specifies a required labeling statement ("This is not a stand-alone device. It should be used in conjunction with your present contraceptive method").

Neither letter includes the detailed study information you've requested regarding device performance and validation.

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